Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off Episodes
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2012-12-31, after 2012-05-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2012-12-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Design: crossover (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: parkinsonto determinemotordiseasestable
Phrases that lowered it: pharmacokineticspharmacodynamicssafetyefficacy andday -
Accepts healthy volunteers: No (raises risk) · Who can join
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Minimum age: 30 (lowers risk) · Who can join
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Sponsor's past termination rate: 10% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 4 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 11.2% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 74.6% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 10 (lowers risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 6 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 30 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 10 (typical: 32)
- Sponsor's past termination rate
- 10% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 11695 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1690 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- carbidopa, carbidopa levodopa, levodopa
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes NCT01777555 · started 2013 · scored riskier than 15% of active trials completed
- Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes NCT02240030 · started 2014 · scored riskier than 12% of active trials completed
- A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder) NCT02807675 · started 2016 · scored riskier than 8% of active trials completed
- Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes NCT02242487 · started 2015 · scored riskier than 14% of active trials completed
- Randomized Safety Study of CVT-301 Compared to an Observational Control Group NCT02352363 · started 2015 · scored riskier than 32% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.